FDA warns 2nd company of 'significant violations' in lead tests

FDA warns 2nd company of 'significant violations' in lead tests

Author:
Carrie Blackmore Smith, Cincinnati Enquirer

Published:
2:16 PM EST January 12, 2018

Updated:
4:16 PM EST January 12, 2018

Wilson Hardy of Cincinnati, who will be 2 in February, is photographed with his mom, Shar Allen Hardy. Wilson's doctors believe lead poisoning stunted his growth. When his family couldn't pinpoint a source of the poison, they moved and his condition started improving.

FDA officials issued a warning letter Thursday to Becton Dickinson & Co. of Franklin Lakes, N.Y., which makes the plastic tubes that held blood samples in the faulty tests.

Becton Dickinson (BDX) modified some of its blood tubes without FDA permission, according to an FDA news release. The 120-year-old company also failed to provide medical device reports to the federal agency on time.

"We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results," Donald St. Pierre, the FDA's deputy director of new product evaluation, said in a news release.

The FDA recalled 7 million tests from 2014 to early 2017 after a popular lead testing system, manufactured Magellan Diagnostics of North Billerica, Mass., produced an unknown number of falsely low results. The recall triggered a Centers for Disease Control and Prevention call to retest some of the millions of children who had taken the tests that used blood drawn from veins rather than pin-pricked capillaries.

No level of lead is considered safe in children.

Those whose blood is shown to have 5 micrograms of lead and higher per deciliter of blood are among 2.5% of children ages 1 to 5 who have been tested across the USA with the highest blood lead levels. They're advised to be under a doctor's care to lower those lead levels because even a small amount of lead in the blood affects children's IQ, attention span and academic achievement.

Becton Dickinson is treating the citations and orders in the warning letter "with the highest sense of urgency," Richard Byrd, worldwide president of BD Preanalytical Systems, said in a prepared statement.

"Ensuring the safety and quality of our products is our top priority at BD," Byrd said in the statement. "We take any potential issue with our products very seriously and are cooperating fully with the FDA on this matter."

Becton Dickinson's stock price rose about 0.8% Friday on the New York Stock Exchange and was trading at $227.71 as the market closed.

If the FDA isn't satisfied that its warning letter results in prompt corrections, the agency can take additional actions, including seizure, injunction and civil monetary penalties.

The FDA also determined that Becton Dickinson received a complaint from Magellan Diagnostics, makers of the lead testing systems, which had found a link between certain tubes and inaccurate test results.

"We told (BD) we thought it was the problem, and they said it wasn't their problem," said President and Chief Executive Jack Kenny of Meridian Bioscience, the Newtown, Ohio-based parent of Magellan. His company informed its LeadCare customers to stop using those blood tubes with the diagnostic device.

"We tried to do what was right," Kenny said.

However, the FDA also warned Magellan for violating federal laws regarding how to report complaints and make changes to its medical devices.

Mother of two, Mariah Roseberry holds her son, Hudson, 17 months, as she answers questions about lead poisoning risk factors in her home in the Price Hill neighborhood of Cincinnati on Friday, Jan. 5, 2018. Hudson tested at a blood lead level of 5.4. Medical professionals consider anything higher than 5.0 to be lead poisoning.